Modified Thoracoabdominal Nerve Plane Block In Living Liver Donors

NCT06300372 | Completed

• 1 other identifier: Medipol Hospital 2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed deep into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. As there are studies showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery.

Conditions

Liver Failure; Acute Postoperative Pain

Keywords

Modified Thoracoabdominal Nerve Plane Block; Liver Transplantation; Acute Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Opioid consumption (Fentanyl PCA)

  The primary aim is to compare postoperative opioid consumption from the PCA device.

  Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours

Secondary Outcomes (3)

• Pain scores (Numerical rating scale-NRS

  Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours]

• Need for rescue analgesia (meperidine)

  Postoperative 48 hours period

• Adverse events

  Postoperative 48 hours period

Study Arms (2)

Group A=M-TAPA block group

EXPERIMENTAL

M-TAPA plane block will be performed and standard postoperative pain management protocols will be applied.

Procedure: M-TAPA plane block; Procedure: Postoperative pain management

Group B = control group

ACTIVE COMPARATOR

Only standard postoperative pain management protocols will be applied. No plane blocks will be applied

Procedure: Postoperative pain management

Interventions

M-TAPA plane block PROCEDURE

As the patient is in the supine position, the high-frequency linear US probe (11-12 MHz, Vivid Q) and a 22-G 80-mm needle (Pajunk Sonoplex Nanoline Stim Cannula, Germany) will be placed in a sagittal position at the costochondral junction at the level of the 9th and 10th ribs. After the rib and the external oblique, internal oblique, and transversus abdominis muscles are visualized on USG, using an in-plane technique, the block needle will be advanced and the block location will be confirmed by injecting 5 ml of saline between the internal oblique and transversus abdominis muscles. Once the block location is confirmed, 30 ml of 0.25% bupivacaine (Buvicaine ®) will be applied bilaterally (60 ml in total).

Group A=M-TAPA block group

Postoperative pain management PROCEDURE

For preemptive analgesia, morphine (Morfin ®) 0.05mg/kg and Ibuprofen 400mg IV (Ibuprofen®) will be administered to all patients before the surgical incision. An additional dose of ibuprofen 400mg IV, meperidine (Aldolan ®), and tramadol (Contramal®) 1mg/kg IV will be administered to all patients 30 minutes before wound closure.10 mcg/ml fentanyl containing PCA will be connected to all patients without infusion and boluses 0,35 mcg/kg,15-minute lockout period, maximum 100 mcg per hour. Postoperative patient evaluation will be performed by another anesthesiologist. If the NRS score is ≥ 4, 0.5 mg/kg IV meperidine (Aldolan®)will be administered as a rescue analgesic.

Group A=M-TAPA block group; Group B = control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• with history of bleeding diathesis,
• receiving anticoagulant treatment,
• with allergies or sensitivity to drugs used,
• with an infection on the puncture site
• who do not accept the procedure or participate in the study

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University Mega Hospital Complex

Istanbul, Bagcilar, Turkey (Türkiye)

Location

Related Publications (7)

• Yong BH, Tsui SL, Leung CC, Lo CM, Liu CL, Fan ST, Young K. Management of postoperative analgesia in living liver donors. Transplant Proc. 2000 Nov;32(7):2110. doi: 10.1016/s0041-1345(00)01592-x. No abstract available.

  PMID: 11120091 BACKGROUND

• Hacibeyoglu G, Topal A, Arican S, Kilicaslan A, Tekin A, Uzun ST. USG guided bilateral erector spinae plane block is an effective and safe postoperative analgesia method for living donor liver transplantation. J Clin Anesth. 2018 Sep;49:36-37. doi: 10.1016/j.jclinane.2018.06.003. Epub 2018 Jun 5. No abstract available.

  PMID: 29883965 BACKGROUND

• Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.

  PMID: 20830871 BACKGROUND

• Tulgar S, Senturk O, Selvi O, Balaban O, Ahiskalioglu A, Thomas DT, Ozer Z. Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:8-10. doi: 10.1016/j.jclinane.2018.10.015. Epub 2018 Oct 31. No abstract available.

  PMID: 30388604 BACKGROUND

• Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.

  PMID: 30639940 BACKGROUND

• Aikawa K, Tanaka N, Morimoto Y. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides a sufficient postoperative analgesia for laparoscopic sleeve gastrectomy. J Clin Anesth. 2020 Feb;59:44-45. doi: 10.1016/j.jclinane.2019.06.020. Epub 2019 Jun 15. No abstract available.

  PMID: 31212124 BACKGROUND

• Gungor H, Ince A, Ciftci B, Emre Golboyu B, Asici M, Karaaslan P, Yanaral TU. Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach for Postoperative Analgesia Management in Living Liver Donors: A Randomized, Prospective, Controlled Study. Clin Transplant. 2025 Sep;39(9):e70224. doi: 10.1111/ctr.70224.

  PMID: 40892532 DERIVED

MeSH Terms

Conditions

Liver Failure; Pain, Postoperative

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor and participants will be blinded to the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Fifty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II, scheduled for living liver donation surgery for liver transplantation will be included in the study. Patients will be randomly divided into two groups (Group A=M-TAPA block group, Group B = control group) including 25 patients each, before entering the operating room.

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 8, 2024
• Study Start: April 1, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)